Myelodysplastic Syndrome Clinical Trial

A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

Summary

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants:

Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept
Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met
The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase
Transition Phase is defined as one Enrollment visit
Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol

Follow-up Phase includes:

- 42 Day Safety Follow-up Visit

During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting

- Long-term Post-treatment Follow-up (LTPTFU) Phase

Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule

Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study.

The rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill at least 5 years from the first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must meet all the following criteria to be enrolled in this study:

Participant is ≥ 18 years at the time of signing the informed consent form (ICF).
Participant is willing and able to adhere to the study visit schedule and other protocol requirements.

Participant has been participating in a luspatercept trial and continues to fulfill all the requirements of the parent protocol and the participant has been either:

Assigned to luspatercept treatment, continues to receive clinical benefit in the opinion of the investigator and should continue to receive luspatercept treatment, OR
Assigned to placebo arm in the parent protocol (at the time of unblinding or in follow-up) and should cross over to luspatercept treatment, OR
Assigned to the Follow-up Phase of the parent protocol, previously treated with luspatercept or placebo in the parent protocol who shall continue into Long-term Post-treatment Follow-up Phase in the rollover study until the follow-up commitments are met (unless requirements are met as per parent protocol to crossover to luspatercept treatment).
Participant understands and voluntarily signs an informed consent document prior to any study-related assessments or procedures being conducted.
Participant demonstrates compliance, as assessed by the investigator, with the parent study protocol requirements.
Applies to on treatment Participants only- females of childbearing potential (FCBP) defined as a sexually mature woman who:

1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy or amenorrhea due to other medical reasons does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) and must:

Have two negative pregnancy tests as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the participant practices true abstinence* from heterosexual contact.

Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with highly effective, contraception without interruption, 35 days prior to starting investigational product (IP), during the study therapy (including dose interruptions), and for 84 days after discontinuation of study therapy.

7. Applies to on treatment participants only- Male participants must:

a. Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 84 days following investigational product discontinuation even if he has undergone a successful vasectomy.

Exclusion Criteria:

The presence of any of the following will exclude a participant from enrollment:

Applies to on treatment participants only- Concomitant use of any medications/procedures that are prohibited in the parent luspatercept protocol.
Participant has met one or more criteria for study discontinuation as stipulated in the parent luspatercept protocol.
Applies to on treatment participants only- More than 26 days between last luspatercept dose in the parent protocol and first dose into ACE-536-LTFU-001 protocol unless dose delay or dose discontinuation criteria met.
Applies to on treatment participants only- Pregnant or breastfeeding females.
Participant has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (eg, imprisoned or institutionalized) that would prevent the subject from participating in the study.
Participant has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
Participant has any condition that confounds the ability to interpret data from the study.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

665

Study ID:

NCT04064060

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 137 Locations for this study

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Childrens Hospital Los Angeles RHU
Los Angeles California, 90027, United States More Info
Thomas Coates, Site 968
Contact
323-361-2352
Local Institution - 971
Oakland California, 94609, United States
Local Institution - 978
Stanford California, 94305, United States
Local Institution - 975
Tampa Florida, 33612, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago Illinois, 60611, United States More Info
Sherif Badawy, Site 970
Contact
Boston Children's Hospital
Boston Massachusetts, 02115, United States More Info
Erica Esrick, Site 973
Contact
617-355-2569
Local Institution - 961
Detroit Michigan, 48201, United States
Local Institution - 969
New York New York, 10065, United States
Local Institution - 967
Cleveland Ohio, 44195, United States
Local Institution - 972
Philadelphia Pennsylvania, 19104, United States
Vanderbilt - Ingram Cancer Center
Nashville Tennessee, 37232, United States
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Local Institution - 100
South Brisbane Queensland, 4101, Australia
Local Institution - 103
Adelaide South Australia, 5000, Australia More Info
Site 103
Contact
Local Institution - 102
Clayton Victoria, 3168, Australia
Royal Prince Alfred Hospital
Camperdown , 2050, Australia More Info
Phoebe Joy Ho, Site 101
Contact
+61295158031 0 0000
Local Institution - 182
Brasschaat , 2930, Belgium
Local Institution - 180
Brugge , 8000, Belgium
Local Institution - 183
Ghent , 9000, Belgium
Local Institution - 184
Leuven , 3000, Belgium
Local Institution - 220
Boulevard Sofia, 1797, Bulgaria More Info
Site 220
Contact
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv , 4002, Bulgaria More Info
Pencho Georgiev, Site 221
Contact
+359888520139
Local Institution - 262
Toronto Ontario, M4N 3, Canada
University Health Network
Toronto Ontario, M5G 2, Canada More Info
Kevin Kuo, Site 260
Contact
4163405233
Local Institution - 263
Toronto Ontario, M5G 2, Canada
Local Institution - 131
Beijing Beijing, 10073, China
Local Institution - 135
Guangzhou Guangdong, 51051, China
Local Institution - 132
Shanghai Shanghai, 20023, China More Info
Site 132
Contact
Local Institution - 134
Chengdu Sichuan, 61004, China More Info
Site 134
Contact
Local Institution - 130
Tianjin Tianjin, 30002, China More Info
Site 130
Contact
Local Institution - 133
Hangzhou Zhejiang, 31000, China More Info
Site 133
Contact
Local Institution - 305
Angers , 49033, France
Local Institution - 300
Creteil , 94010, France More Info
Site 300
Contact
Local Institution - 310
La Tronche , 38700, France
CHRU de Lille-Hopital Claude Huriez
Lille , 59037, France More Info
Laure Goursaud, Site 306
Contact
Local Institution - 301
Marseille Cedex 9 , 13385, France
Local Institution - 302
Paris , 75010, France
Local Institution - 307
Pessac Cedex , 33604, France
Local Institution - 304
Pierre Benite cedex , 69495, France
Local Institution - 308
Strasbourg , 67091, France
Local Institution - 309
Toulouse Cedex 9 , 31059, France
Local Institution - 303
Tours , 37044, France
Local Institution - 341
Berlin , 14195, Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden
Dresden , 01307, Germany More Info
Katja Sockel, Site 348
Contact
493514587666
Universitaetsklinikum Duesseldorf
Duesseldorf , 40225, Germany More Info
Ulrich Germing, Site 345
Contact
+492118117780
Local Institution - 346
Dusseldorf , 40479, Germany
Local Institution - 343
Halle , 06120, Germany
Local Institution - 342
Hamburg , 22081, Germany More Info
Site 342
Contact
Local Institution - 344
Hannover , 30625, Germany
Local Institution - 349
Leipzig , 04103, Germany
Local Institution - 340
Mainz , 55131, Germany More Info
Site 340
Contact
Klinikum Rechts der Isar der Technischen Universitaet Muenchen
München , 81675, Germany More Info
Katharina Goetze, Site 347
Contact
+498941405618 00 00
Aghia Sophia' Children's General Hospital of Athens
Athens , 115 2, Greece More Info
Antonis Kattamis, Site 382
Contact
+302107467772 0(000)
Laiko General Hospital of Athens - Center of Thalassemia
Athens , 115 2, Greece More Info
Maria Dimopoulou, Site 380
Contact
Local Institution - 384
Athens , 11527, Greece
Local Institution - 383
Rio Patras , 26500, Greece
General Hospital of Thessaloniki Hippokration
Thessaloniki , 54642, Greece More Info
Efthymia Vlachaki, Site 381
Contact
302310892003
Local Institution - 425
Afula , 18341, Israel
Local Institution - 420
Haifa , 31096, Israel More Info
Site 420
Contact
Local Institution - 422
Jerusalem , 91031, Israel
Local Institution - 424
Jerusalem , 91120, Israel
Galilee Medical Center
Nahariya , 22100, Israel More Info
Celia Suriu, Site 421
Contact
Local Institution - 423
Petah Tikva , 49100, Israel
Azienda Ospedaliera Universitaria Careggi
Firenze Toscana, 50134, Italy More Info
Valeria Santini, Site 478
Contact
+390557947296 000 0
Local Institution - 471
Firenze Toscana, 50139, Italy
Local Institution - 470
Allessandria , 15100, Italy
Local Institution - 464
Bologna , 40138, Italy
Local Institution - 466
Brindisi , 72100, Italy
Azienda Sanitaria Locale (ASL) Cagliari - Ospedale Regionale per le Microcitemie
Cagliari , 09121, Italy More Info
Raffaella Origa, Site 477
Contact
+390706095655 00000
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
Ferrara , 44124, Italy More Info
Maria Rita Gamberini, Site 462
Contact
+390532237349
Ente Ospedaliero Ospedali Galliera - Centro della Microcitemia e delle Anemie Congenite
Genoa , 16128, Italy More Info
Manuela Balocco, Site 476
Contact
+390105634557
Local Institution - 473
Lecce , 73100, Italy
Maggiore Polyclinic Hospital, IRCCS Ca' Granda
Milano , 20122, Italy More Info
Maria Domenica Cappellini, Site 467
Contact
+390250320288
Local Institution - 479
Modena , 41124, Italy
AORN A Cardarelli
Napoli , 80131, Italy More Info
Paolo Ricchi, Site 475
Contact
AOU dell'Università degli Studi della Campania Luigi Vanvitelli
Napoli , 80131, Italy More Info
Silverio Perrotta, Site 461
Contact
+0390815665421 0 000
Azienda Ospedaliero Universitaria S. Luigi Gonzaga
Orbassano , 10043, Italy More Info
Giovanni Battista Ferrero, Site 460
Contact
Irccs Policlinico San Matteo
Pavia , 27100, Italy More Info
Luca Malcovati, Site 469
Contact
+39 0382 503084
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Di Calabria , 89124, Italy More Info
Esther Oliva, Site 468
Contact
+39 0965 393903
Local Institution - 465
Roma , 133, Italy
Local Institution - 474
Rozzano , 20089, Italy
Ospedale di Circolo di Varese
Varese , 21100, Italy More Info
Marco Brociner, Site 472
Contact
Local Institution - 463
Verona , 37134, Italy More Info
Site 463
Contact
Local Institution - 610
Nagoya Aichi, 460-0, Japan More Info
Site 610
Contact
Local Institution - 601
Kamogawa Chiba, 296-0, Japan
Local Institution - 606
Matsuyama Ehime, 790-8, Japan More Info
Site 606
Contact
Ogaki Municipal Hospital
Ogaki Gifu, 503-8, Japan More Info
Hiroshi Kosugi, Site 608
Contact
81584813341
Local Institution - 614
Himeji Hyogo, 670-8, Japan More Info
Site 614
Contact
Hitachi General Hospital
Hitachi Ibaraki, 317-0, Japan More Info
Atsushi Shinagawa, Site 605
Contact
+01294231111
Local Institution - 603
Sagamihara Kanagawa, 252-0, Japan More Info
Site 603
Contact
Local Institution - 0979
Sendai Miyagi, 980-8, Japan
Tohoku University Hospital
Sendai Miyagi, 980-8, Japan More Info
Koichi Onodera, Site 607
Contact
Local Institution - 611
Nagasaki-shi Nagasaki, 85285, Japan
Local Institution - 602
Shibuya City Tokyo, 150-8, Japan More Info
Site 602
Contact
Local Institution - 600
Shinagawa City Tokyo, 141-8, Japan More Info
Site 600
Contact
Local Institution - 612
Chiba , 260-0, Japan
Local Institution - 613
Kamakura , 247-8, Japan More Info
Site 613
Contact
Local Institution - 609
Osaka , 545-8, Japan More Info
Site 609
Contact
Local Institution - 604
Osaka , 589-8, Japan More Info
Site 604
Contact
Chronic Care Center
Hazmieh , 00961, Lebanon More Info
Ali Taher, Site 500
Contact
+9613755669 000000.0
Hospital Sultanah Aminah
Johor Bahru Johor, 80100, Malaysia More Info
Soo Min Lim, Site 545
Contact
+6072223037
Hospital Sultanah Bahiyah
Alor Setar Kedah, 05460, Malaysia More Info
Hong Keng Liew, Site 542
Contact
6047406191
Local Institution - 546
Ipoh Perak, 30990, Malaysia More Info
Site 546
Contact
Queen Elizabeth Hospital
Kota Kinabalu Sabah, 88586, Malaysia More Info
Lily Wong, Site 543
Contact
6088517507
Hospital Umum Sarawak
Kuching Sarawak, 93586, Malaysia More Info
Lee Ping Chew, Site 540
Contact
+60165518129
University Malaya Medical Centre
Kuala Lumpur Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia More Info
Ping Chong Bee, Site 544
Contact
+60123048771
Local Institution - 580
Amsterdam , 1081 , Netherlands
Local Institution - 681
Barakaldo , 48903, Spain
Local Institution - 685
Barcelona , 08035, Spain
Local Institution - 686
Barcelona , 08908, Spain
Local Institution - 687
Madrid , 28028, Spain
Local Institution - 682
Oviedo , 33011, Spain
Local Institution - 684
Salamanca , 37007, Spain
Local Institution - 680
Seville , 41013, Spain
Local Institution - 683
Valencia , 46026, Spain
Local Institution - 720
Goteborg , 413 4, Sweden
Local Institution - 722
Lund , SE-22, Sweden
Local Institution - 721
Stockholm , 141 8, Sweden
Local Institution - 760
Kaohsiung, San Ming Dist. , 807, Taiwan More Info
Site 760
Contact
China Medical University Hospital
Taichung , 40447, Taiwan More Info
Ching-Tien Peng, Site 762
Contact
886422052121ext4636
National Taiwan University Hospital
Taipei , 10022, Taiwan More Info
Meng-Yao Lu, Site 761
Contact
+886223123456
Chulalongkorn University Faculty of Medicine - King Chulalongkorn Memorial Hospital
Bangkok , 10330, Thailand More Info
Pranee Sutcharitchan, Site 800
Contact
+66022564564
Siriraj Hospital Mahidol University
Bangkok , 10700, Thailand More Info
Vip Viprakasit, Site 802
Contact
6624122113
Chiang Mai University - Maharaj Nakorn Chiang Mai Hospital
Chiang Mai , 50200, Thailand More Info
Adisak Tantiworawit, Site 801
Contact
+66815688875
Local Institution - 840
Sousse , 4031, Tunisia More Info
Site 840
Contact
Bone Marrow Transplant Center
Tunis , 1006, Tunisia More Info
Monia Ouederni, Site 841
Contact
+21693184151 0000 00
Local Institution - 842
Tunis , 1008, Tunisia More Info
Site 842
Contact
Military Hospital of Tunis
Tunis , 1008, Tunisia More Info
Fehmi M'Sadk, Site 843
Contact
+21671393490
Acibadem Adana Hospital
Adana , 01130, Turkey More Info
Ali Bulent Antmen, Site 881
Contact
+903224554444
Local Institution - 885
Ankara , 06590, Turkey
Local Institution - 882
Istanbul , 34093, Turkey
Local Institution - 884
Istanbul , 34098, Turkey
Ege Universitesi Tip Fakultesi Hastanesi
Izmir , 35100, Turkey More Info
Yesim Aydinok, Site 880
Contact
+9023244413433711
Local Institution - 883
Mersin , 33343, Turkey
Local Institution - 925
Aberdeen , AB25 , United Kingdom
Local Institution - 921
Leeds , LS9 7, United Kingdom
Local Institution - 923
London , E1 1B, United Kingdom
Local Institution - 920
London , N19 5, United Kingdom More Info
Site 920
Contact
Local Institution - 922
London , NW1 2, United Kingdom More Info
Site 922
Contact
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London , SE1 9, United Kingdom More Info
Claire Harrison, Site 928
Contact
+442071882742
Kings College Hospital
London , SE5 9, United Kingdom More Info
Shreyans Gandhi, Site 924
Contact
Local Institution - 929
Oxford , OX3 7, United Kingdom
Local Institution - 926
Sutton in Ashfield , NG17 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

665

Study ID:

NCT04064060

Recruitment Status:

Recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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